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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker TOM

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  Class 2 Device Recall Stryker TOM see related information
Date Initiated by Firm December 22, 2006
Date Posted February 27, 2007
Recall Status1 Terminated 3 on June 04, 2008
Recall Number Z-0521-2007
Recall Event ID 37067
Product Classification bone mill - Product Code LXH
Product Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker Leiblinger Inc., Kalamazoo, MI; Part 01-15407.
Code Information Lots G4C00F72HN, G5H00F72HN, G7T00F72HN, G8W00F72HN and G9700F72HN.
Recalling Firm/
Manufacturer		 Stryker Leibinger USA
750 Trade Center Way Ste 200
Portage MI 49002-0482
Manufacturer Reason
for Recall		 Metal shavings come off of the plug as a result of friction between the plug and the cutting cylinder, and may be mixed with the milled bone chips.
FDA Determined
Cause 2		 Other
Action Consignees were notified via recall letter dated 12/22/06 which instructed them to quarantine the product and to contact the firm for further instructions.
Quantity in Commerce 26
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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